FDA Fails To Pursue Off-Label Violations: Report

The FDA takes an average of seven months to issue warnings to drugmakers for off-label marketing, and the drugmakers take an average of four months to address violations, according to the Associated Press, citing a report compiled by the Government Accountability Office. Here it is.

The report also found the FDA has no one assigned to specifically monitor off-label violations. The agency’s Division of Drug Marketing, Advertising and Communications, which has 44 employees reviewing DTC ads, monitors off-label marketing.

The division examined about 68,000 ads last year, but lacks the resources to review all info received by the FDA, according to the report. The agency uses a prioritization system to select which ads should be reviewed, but the GAO found no evidence the FDA “systematically prioritizes all the submissions it receives.” In other words, the agency isn’t applying its own criteria to most submissions. (see page 40).

From 2003 to 2007, DDMAC issued 42 notices of potential violations related to off-label use, most of which prompted drugmakers to end misrepresentations in their ads. Another 11 cases involving off-label promotion were pursued by the Justice Department during the same period.

Chuck Grassley, the Republican Senator from Iowa, who requested the report, issued a statement saying the FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law As a result, drugmakers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

UPDATE: An astute reader reminds us that, earlier this year, drugmakers began lobbying Washington to push for looser government restrictions on off-label promotion. Ten drugmakers, including Pfizer, Bayer, AstraZeneca and Johnson & Johnson, formed a coalition to push for looser off-label restrictions with an eye toward submitting comments to the FDA, which has been soliciting comments on its proposed off-label promotion guidelines.